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Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM

Primary Purpose

Gestational Diabetes, Glucose Intolerance During Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oral glucose tolerance test
Sponsored by
Ankara City Hospital Bilkent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gestational Diabetes

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women

Exclusion Criteria:

  • Already diagnosed by diabetes mellitus
  • Multiple pregnancy

Sites / Locations

  • Ankara City HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

50 gr-100 gr OGTT

75 gr OGTT

Arm Description

patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT

patients are tested by 75 gr OGTT

Outcomes

Primary Outcome Measures

the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
to determine the ideal diagnostic test

Secondary Outcome Measures

Full Information

First Posted
October 9, 2020
Last Updated
February 18, 2022
Sponsor
Ankara City Hospital Bilkent
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1. Study Identification

Unique Protocol Identification Number
NCT04585204
Brief Title
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Official Title
Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2020 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Glucose Intolerance During Pregnancy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2282 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
50 gr-100 gr OGTT
Arm Type
Active Comparator
Arm Description
patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT
Arm Title
75 gr OGTT
Arm Type
Active Comparator
Arm Description
patients are tested by 75 gr OGTT
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral glucose tolerance test
Intervention Description
Oral glucose tolerance test
Primary Outcome Measure Information:
Title
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
Description
to determine the ideal diagnostic test
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women Exclusion Criteria: Already diagnosed by diabetes mellitus Multiple pregnancy
Facility Information:
Facility Name
Ankara City Hospital
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seval Erdinç
Phone
00905054884144
Email
sevalerdinc@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Comparison of the Detection Rates of 50 Gr-100 gr OGTT and 75 gr OGTT That Require Medical Treatment of GDM

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